Dual Lumen Endobronchial Tube Device

ABSTRACT

The present invention provides improved dual lumen endobronchial tube devices. The dual lumen endobronchial tube devices feature a universal design for left or right mainstem bronchus insertion. The dual lumen endobronchial tube devices also feature enhanced balloon cuff designs to minimize dislodgement while maintaining proper airway sealing. The present invention also includes water activated lubricious coating inside the shaft to reduce friction during insertion of a bronchoscope into the airway. The present invention also provides improved double clamps that prevent the accidental clamping of both tubes of a Y-adapter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/829,509, filed Mar. 14, 2013, which is entitled to priorityto U.S. Provisional Patent Application No. 61/690,867, filed Jul. 6,2012, the contents of which are each incorporated by reference herein intheir entirety. This application is also entitled to priority to U.S.Provisional Patent Application No. 62/285,592, filed Nov. 3, 2015, whichis incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Lung isolation and single lung ventilation are routinely institutedduring thoracic surgery. Surgery involving the lung or the contents ofthe thorax often requires cessation of ventilation to one lung for twomain reasons: 1) to keep the lung immobile while surgery on it isperformed and 2) to deflate the lung for better visualization ofthoracic structures. Other indications for lung isolation include: 1)containment of unilateral pulmonary bleeding or infection, 2) managementof bronchopleural fistula or other unilateral pulmonary air leaks, and3) differential lung ventilation in the critical care setting. Today,the gold standard for lung isolation is the double lumen endobronchialtube (DLT). Modern disposable plastic DLTs are modifications of theoriginal Robert-Shaw tube introduced more than sixty years ago. Theseendotracheal tubes contain two separate lumens, one for each lung, andventilation is separated with the use of endotracheal and endobronchialballoon cuffs.

The DLT design suffers from several major drawbacks that negativelyaffect clinical care. The first is the large size of the tube, namelyits effective outer diameter (OD). The four current adult-sized DLTs are35, 37, 39, and 41 French in external circumference; this large size isneeded to accommodate the necessary plastic structure and ventilationpassages. Aside from being large, the DLTs are also reasonably stiff dueto the plastic material used in their construction. Furthermore, thedevice's shaft is pre-bent into set angles designed to circumnavigatethe anatomic curvature of the human airway. The combination of theirlarge and bulky design and their stiffness with pre-set angles can leadto difficult insertion and even airway injury. Even if insertion isatraumatic, the DLT's large external diameter increases the pressure onthe vocal cords, potentially injuring these delicate structures,especially during prolonged intubations.

The pre-determined shaft angles are designed for the “average” personand do not necessarily match up with an individual patient's anatomy.

The second major design drawback is the relatively small size of theventilation passages in the current DLT. Even the current bulky designhouses two relatively small diameter channels, thus limiting the size ofbronchoscopes, suction catheters, and other instruments that could beinserted into the lungs during use. No adult DLT sizes (35-41 Fr) canaccommodate a pulmonary bronchoscope needed to perform diagnostic ortherapeutic bronchoscopy (minimum 5.0 mm OD). If a diagnostic ortherapeutic bronchoscopy exam is to be performed (e.g., suction/lavage,bronchial biopsy, bronchial laser) prior to surgical lung resection, astandard large bore endotracheal tube must first be utilized for thispart of the procedure to accommodate the large bore bronchoscope. Oncethe bronchoscopy is completed, the endotracheal tube must be removed anda DLT put in its place, a procedure that can be fraught with risk. Thelimited lumen diameter of DLTs poses a special clinical challenge when apatient is bleeding from one lung and lung isolation is warranted.Although a DLT is ideal for lung isolation to prevent flooding the goodlung with blood (possibly causing patient asphyxiation and death),placement of a DLT severely limits one's ability to perform thediagnostic and therapeutic bronchoscopy necessary to treat this medicalemergency. Furthermore, the standard DLT's small airways essentiallydisqualify it from being used in the intensive care unit (ICU) settinggiven the need for intermittent and repeating bronchoscopy and airwaysuctioning (pulmonary toilet).

A third major limitation is that the DLT's long tube length combinedwith its small diameter lumens make even a small bronchoscope (4.0 mmOD) difficult to insert due to significant friction between the scopeshaft and tube inner diameter (ID). Successful bronchoscope insertionrequires repeated application of lubricant to the scope shaft, utilizingeither water-based or other (e.g., silicone-based) lubricants. Becausethese lubricants inevitably dry up or get consumed in the process of theexamination, the bronchoscope is often difficult to slide in the deviceand may even sustain damage or become stuck in the tube shaft.

A fourth major limitation of the standard DLT is that its tracheal andbronchial balloon cuffs are the standard elliptical shape with smoothsurfaces. Once inflated, and in the moist setting of the human airway,these balloons easily slip, leading to device dislodgement. Movement of10 mm or even less can lead to clinically significant devicemalpositioning. Such dislodgement can be at a minimum a significantdisruption to the surgery given the loss of lung isolation, and at theextreme can cause severe life threatening hypoxemia (from obstructedoxygen flow and/or lung contamination). Given the unstable nature of thedevice's positioning, clinicians are trained to continuously evaluatethe device's position within the airway to ensure that it does notdislodge.

A fifth significant limitation is that the DLT comes in two differentconfigurations, left-sided and right-sided, depending on which bronchusthe distal tip is expected to reside in. Although the majority of casesutilize a left-sided tube, for technical reasons a right-sided tube mayneed to be used, and in rare cases it is not clear at the beginning ofthe case which type of tube would best fit a particular patient. Becauseall four adult sizes (35, 37, 39, 41 Fr) must be available in a left- orright-sided configuration, the inventory must contain 8 different devicesizes/configurations for adult patients, making device selection as wellas inventory management a challenge.

A sixth significant limitation involves the need for clamping one limbof a standard Carlens Y adapter to initiate one lung ventilation (OLV).This standard adapter serves the usual dual function of 1) allowing forsimultaneous ventilation of both lumens with one ventilator and 2)allowing for bronchoscopy to be performed during positive pressureventilation. Traditionally, the anesthesiologist would borrow astainless steel surgical clamp from the field to physically clamp andocclude the appropriate limb of the Y adapter. The weight of this clampwould often torque the whole tube assembly and cause a dislodgement.Although attaching an integrated plastic tubing clamp onto the Y-piececould be a logical solution, this would require two clamps to beintegrated into the device (one on each limb). Changing from oneexternal clamp to two integrated clamps raises the potential risk thatboth clamps are simultaneously closed accidentally, as could happen whenthe ventilation is switched from one lung to the other. Failure torecognize this error could lead to severe hypoxemia and even deathcaused by the inability to ventilate the patient and the lack ofrecognition that this is a device malfunction and not a patientcomplication.

A seventh significant limitation is the inability to directly measurethe pressure in the balloon cuffs. Often, the balloons have to beinflated taut to prevent unintended lung inflation during OLV,especially the bronchial cuff. The lack of being able to measure thereal time pressure in the balloon cuff puts the patient at potentialrisk of tracheal/bronchial injury.

There is a need in the art for improved dual lumen endobronchialdevices. The present invention meets this need.

SUMMARY OF THE INVENTION

The present invention relates to a universal dual lumen endobronchialdevice, comprising: a straight shaft having a proximal end and a distalend; a curved bronchial tube extending from the distal end of thestraight shaft; a tracheal lumen within the shaft extending from theproximal end of the shaft to a tracheal lumen opening at the distal endof the shaft; a bronchial lumen within the shaft extending from theproximal end of the shaft to a bronchial lumen opening at a distal endof the bronchial tube; a tracheal balloon cuff proximally adjacent tothe tracheal lumen opening; and a bronchial balloon cuff proximallyadjacent to the bronchial lumen opening; wherein the straight shaft andthe curved bronchial tube are constructed from a polymer having a ShoreA hardness between 60 and 95.

In one embodiment, the proximal end of the straight shaft comprises aY-connector fluidly connected to the tracheal lumen and the bronchiallumen. In one embodiment, the straight shaft further comprises one ormore inflation lumens fluidly connected to the tracheal balloon cuff,the bronchial balloon cuff, or both.

In one embodiment, the tracheal lumen and the bronchial lumen areseparated by a flexible semilunar membrane, such that thecross-sectional area of the tracheal lumen and the bronchial lumen aresubstantially equal. In one embodiment, the semilunar membrane has aconvex side adjacent to the tracheal lumen and a concave side adjacentto the bronchial lumen. In one embodiment, the semilunar membrane has aconvex side adjacent to the bronchial lumen and a concave side adjacentto the tracheal lumen. In one embodiment, the semilunar membrane has athickness between 0.45 and 0.55 mm.

In one embodiment, the tracheal lumen and the bronchial lumen areenclosed by a shaft wall having a thickness between 1 and 2 mm. In oneembodiment, the tracheal balloon cuff and the bronchial balloon cuffcomprise one or more raised ridges. In one embodiment, the trachealballoon cuff has a cylindrical shape.

In one embodiment, the bronchial balloon cuff has a trapezoidal sideprofile having a long side and a short side substantially in paralleland a beveled side, such that the long side faces a medial directiontoward the device's tracheal lumen opening, the short side faces alateral direction opposite from the tracheal lumen opening, and thebeveled side is adjacent to the device's bronchial lumen opening andfaces the bronchial lumen opening in a lateral direction away from thetracheal lumen opening.

In one embodiment, the tracheal lumen and the bronchial lumen comprise alubricant layer. In one embodiment, the lubricant layer is wateractivated. In one embodiment, the lubricant layer comprisespolyvinylpyrrolidine (PVP). In one embodiment, the exterior of thestraight shaft and the curved bronchial tube comprise a lubricant layer.

In one embodiment, the device further comprises at least one pressuresensor. In one embodiment, the device further comprises at least oneflow sensor. In one embodiment, the device further comprises at leastone temperature sensor. In one embodiment, the device further comprisesat least one CO2 sensor.

In another aspect, the present invention relates to a double clampdevice, comprising: a planar frame having first and second adjacentslots forming first, second and third tube engagement positions; whereinthe first slot is sized to restrict flow through a tube in the firsttube engagement position, and the second slot is sized to permit flowthrough a tube in the first tube engagement position; wherein the firstslot is sized to permit flow through a tube in the second tubeengagement position, and the second slot is sized to permit flow througha tube in the second tube engagement position; and wherein the firstslot is sized to permit flow through a tube in the third tube engagementposition, and the second slot is sized to restrict flow through a tubein the third tube engagement position. In one embodiment, the devicefurther comprises one or more grips.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of preferred embodiments of theinvention will be better understood when read in conjunction with theappended drawings. For the purpose of illustrating the invention, thereare shown in the drawings embodiments which are presently preferred. Itshould be understood, however, that the invention is not limited to theprecise arrangements and instrumentalities of the embodiments shown inthe drawings.

FIG. 1 depicts an exemplary double lumen endobronchial tube.

FIG. 2 depicts the distal tip of an exemplary double lumen endobronchialtube.

FIG. 3 depicts a cross-sectional diagram of the main shaft of anexemplary double lumen endobronchial tube.

FIG. 4 depicts a cross-sectional diagram of the main shaft of anexemplary double lumen endobronchial tube showing the insertion of alarge bronchoscope.

FIG. 5 depicts an exemplary universal bronchial balloon cuff

FIG. 6 depicts the insertion of an exemplary universal balloon cuff intoa right mainstem bronchus (RMB). Abbreviations: left mainstem bronchus(LMB); right upper lobe (RUL); bronchus intermedius (BI).

FIG. 7A and FIG. 7B depict a comparison between an exemplary universalballoon cuff design of the invention (FIG. 7A) and a traditional ballooncuff design (FIG. 7B). The curve represents the position of a subject'smedial bronchial wall after insertion of the respective devices into theleft mainstem bronchus (LMB), especially when the patient is positionedwith his or her left side down and the mediastinal contents shift downagainst the distal tip.

FIG. 8A and FIG. 8B depict additional universal balloon cuff designs.FIG. 8A is a parallelogram design. FIG. 8B is a curved design.

FIG. 9 depicts an exemplary double clamp and exemplary use.

FIG. 10 depicts an exemplary double clamp having grips.

FIG. 11 depicts the anatomy and average dimensions of the left and rightmainstem bronchus.

FIG. 12 depicts examples of a traditional right-sided double lumenendobronchial tube and a traditional left-sided double lumenendobronchial tube.

FIG. 13 depicts a CT scan of a right mainstem bronchus and its exemplarydimensions (in one individual patient).

FIG. 14 depicts the construction of an ideal balloon cuff

FIG. 15A depicts the placement of an ideal balloon cuff.

FIG. 15B and FIG. 15C depict the placement of poorly dimensioned ballooncuffs. FIG. 15B depicts a balloon cuff that is too long and partiallyoccludes the right upper lobe. FIG. 15C depicts a balloon cuff that istoo short; while it does not occlude the right upper lobe, the shortlength reduces contact surface and increases the likelihood ofdislodgement.

FIG. 16 depicts an experimental setup to test the durability of thesemilunar membrane.

FIG. 17 depicts a further experimental setup to test the durability ofthe semilunar membrane.

FIG. 18 depicts a further experimental setup demonstrating ahypothetical failure in the durability of the semilunar membrane.

FIG. 19 depicts the results of experiments investigating theeffectiveness of several prototype versions of 80 durometer dual lumenendobronchial tube (DLT) main shafts that did not achieve exactdimensions as per the design.

FIG. 20 depicts a comparison between two prototype DLT shaft dimensions.

FIG. 21 depicts the measurements examined in the study investigating theaccuracy of the dimensions of the numerous prototype DLT shafts tested.

FIG. 22 depicts the measurements of dimensions of the numerous prototypeDLT shafts tested.

FIG. 23 depicts the results of investigating numerous prototype DLTshafts having multiple durometers and grooved internal diameters.

FIG. 24 compares several different DLT main shafts that did not achieveexact dimensions as per the design.

DETAILED DESCRIPTION

The present invention provides improved dual lumen endobronchial tubedevices. The dual lumen endobronchial tube devices feature a universaldesign for left or right mainstem bronchus insertion. The dual lumenendobronchial tube devices also feature enhanced balloon cuff designs tominimize dislodgement while maintaining proper airway sealing. Thepresent invention also provides improved integrated double clamps thatprevent the accidental clamping of both tubes of a Y-adapter.

Definitions

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for the purpose of clarity, many other elements typically found in theart. Those of ordinary skill in the art may recognize that otherelements and/or steps are desirable and/or required in implementing thepresent invention. However, because such elements and steps are wellknown in the art, and because they do not facilitate a betterunderstanding of the present invention, a discussion of such elementsand steps is not provided herein. The disclosure herein is directed toall such variations and modifications to such elements and methods knownto those skilled in the art.

Unless defined elsewhere, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, the preferred methodsand materials are described.

As used herein, each of the following terms has the meaning associatedwith it in this section.

The articles “a” and “an” are used herein to refer to one or to morethan one (i.e., to at least one) of the grammatical object of thearticle. By way of example, “an element” means one element or more thanone element.

“About” as used herein when referring to a measurable value such as anamount, a temporal duration, and the like, is meant to encompassvariations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value,as such variations are appropriate.

Throughout this disclosure, various aspects of the invention can bepresented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numberswithin that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6, and anywhole and partial increments there between. This applies regardless ofthe breadth of the range.

Dual Lumen Endobronchial Tube

The present invention provides dual lumen endobronchial tube devicesthat improve upon the limitations of traditional devices. The devices ofthe present invention feature a universal design for left and rightmainstem bronchus insertion. The devices feature improved balloon cuffsfor enhanced fit. The devices feature a semilunar membrane to enable theinsertion of larger diameter instruments than traditionalll deviceshaving comparable dimensions. The devices feature lubricant layers forease of insertion.

Referring now to FIG. 1 and FIG. 2, an exemplary dual lumenendobronchial tube device 10 is depicted. Device 10 comprises anelongate shaft 12 having a longitudinal axis, a proximal end, and adistal end. The proximal end of device 10 comprises Y-connector 14 andpilot balloon/fill valve assembly 16. In some embodiments, the proximalend may further comprise an endotracheal tube holder/bite block forenhanced placement security (not shown). The distal end of device 10comprises tracheal opening 18, bronchial tube 19, bronchial opening 20,tracheal balloon cuff 22, and bronchial balloon cuff 24. Referring nowto FIG. 3, a cross-sectional diagram of shaft 12 is depicted. Shaft 12comprises shaft wall 26 enclosing tracheal lumen 28, bronchial lumen 30,and semilunar membrane 32 separating tracheal lumen 28 and bronchiallumen 30. Shaft 12 further comprises inflation lumens 34.

As described elsewhere herein, in humans, the right mainstem bronchus(RMB) takes a more direct (less angled) takeoff from the trachea,whereas the left mainstem bronchus (LMB) in comparison takes a moreangled takeoff as it comes off the trachea. For this reason, traditionalDLT devices comprise two different designs, a L-sided and a R-sided DLT,which separately incorporate the different angles (FIG. 12). The stiffplastic of traditional DLTs make them a best fit for only theirrespective side. In contrast, shaft 12 and bronchial tube 19 of thepresent invention diverge from traditional endobronchial tube devicesfor universal insertion into either the LMB or the RMB. Shaft 12 iscompletely straight. Bronchial tube 19 has a slight preset curved edgeto correctly line up with either the LMB or the RMB. In certainembodiments, bronchial tube 19 has a preset curve that is less curvedthan a traditional L-sided DLT bronchial tube and more curved than atraditional R-sided DLT bronchial tube. In certain embodiments,bronchial tube 19 has a preset curve that is biased closer to the curveof a traditional L-sided DLT bronchial tube than the curve of atraditional R-sided DLT bronchial tube. Shaft 12 and bronchial tube 19can be constructed from any suitably soft and flexible material, such assilicone, polyvinyl chloride (PVC), and the like. In some embodiments,shaft 12 and bronchial tube 19 are constructed from a silicone having aShore A hardness between 60 and 95. Shaft 12 and bronchial tube 19 arethereby soft and pliant enough to navigate the bends of a subject'strachea and mainstem bronchi and to avoid causing physical trauma to thelining of the subject's trachea and mainstem bronchi. In certainembodiments, shaft 12 and bronchial tube 19 are also rigid enough toprevent buckling, folding, or kinking when inserted into a patient'sairway. In some embodiments, shaft 12 and bronchial tube 19 are stiffenough to be inserted without the aid of a stylet. However, it should beunderstood that shaft 12 and bronchial tube 19 are amenable to acceptinga stylet.

As described above, the cross-sectional diagram of device 10 depicts themultitude of lumens running through the length of shaft 12 enclosed byshaft wall 26. At the center of shaft 12 runs semilunar membrane 32.Semilunar membrane 32 separates tracheal lumen 28 from bronchial lumen30. Semilunar membrane 32 is shaped such that the convex side ofsemilunar membrane 32 is adjacent to tracheal lumen 28 and the concaveside of semilunar membrane 32 is adjacent to bronchial lumen 30. In someembodiments, semilunar membrane 32 can be shaped such that the convexside of semilunar membrane 32 is adjacent to bronchial lumen 30 and theconcave side of semilunar membrane 32 is adjacent to tracheal lumen 28.Semilunar membrane 32 is flexible and may deform by inverting convexitywhen large diameter instruments are inserted into the narrower convexside (FIG. 4). In various embodiments, semilunar membrane 32 may beinelastic or semi-elastic. Semilunar membrane 32 is positioned such thatthe convex lumen and the concave lumen possess the same cross-sectionalarea. Inflation lumens 34 are positioned within shaft wall 26. Tracheallumen 28 extends from a first opening of Y-connector 14 and terminateswith tracheal opening 18. Bronchial lumen 30 extends from a secondopening of Y-connector 14 and terminates with bronchial opening 20.Inflation lumens 34 each extend from a pilot balloon/fill valve assembly16 to tracheal balloon cuff 22 or bronchial balloon cuff 24.

In certain embodiments, the dimensions of shaft 12 are provided withincertain ranges for enhanced performance. Constructing shaft 12 withinthe following dimensions enables shaft 12 to be pliant and adapt to thecurvature of a subject's airway, while retaining enough thickness toprevent kinking during use, which may cut off air supply to a subject.An exemplary thickness of shaft wall 26 can range between 1 and 2 mm. Anexemplary outer diameter (OD) of shaft 12 can range between 12 and 14mm. An exemplary thickness of semilunar membrane 32 can range between0.45 and 0.55 mm; while semilunar membrane 32 may be constructed withdifferent thicknesses, a construction thicker than the stated range maynegatively affect ease of deformation, and a construction thinner thanthe stated range may lead to tearing and perforations caused by insertedinstruments. An exemplary inner diameter (ID) of inflation lumens 34 canbe 0.75 mm. Inflation lumens 34 may be positioned in any suitable partof shaft wall 26. In one embodiment, inflation lumens 34 are positionedat the intersection between shaft wall 26 and semilunar membrane 32.From a manufacturing perspective, this area allows for placement ofinflation lumens 34 in the thickest, most substantial part of shaft wall26, which prevents 1) partial formation with inflation lumens 34breaking out through the edge of shaft wall 26 and 2) wandering of thelocation of inflation lumens 34, which can occur during the highpressure that occurs in extrusion during device construction. Anexemplary device 10 constructed with the abovementioned dimensionsenables the insertion of at least a 6.0 mm OD instrument into tracheallumen 28 and the insertion of at least a 5.0 mm OD instrument intobronchial lumen 30. The overall OD of device 10 can be equivalent to thesmallest traditional adult dual lumen endobronchial tube (DLT) (35 Fr)while having a functional ID greater than even the largest traditionaladult DLT (41 Fr), which cannot accommodate an instrument larger than4.5 mm OD.

Device 10 is secured within the trachea and bronchus of a subject by wayof tracheal balloon cuff 22 and bronchial balloon cuff 24. Trachealballoon cuff 22 is positioned just proximal to tracheal opening 18,forming an airtight seal between tracheal opening 18 and thenon-intubated mainstem bronchus. Bronchial balloon cuff 24 is positionedat the proximal end of the bronchial opening 20, forming an airtightseal between bronchial opening 20 and the intubated mainstem bronchus.In some embodiments, tracheal balloon cuff 22 and bronchial balloon cuff24 comprise one or more ridges 23 for enhanced grip (FIG. 2). Trachealballoon cuff 22 can have any suitable shape commonly used in the art. Insome embodiments, tracheal balloon cuff 22 is substantially cylindrical.

In certain embodiments, bronchial balloon cuff 24 comprises a universaldesign suitable for both LMB and RMB intubation. Referring now to FIG.5, a side profile view of an exemplary universal bronchial balloon cuff24 is depicted. The side profile view of bronchial balloon cuff 24comprises a substantially trapezoidal shape having a long side and ashort side substantially in parallel and a beveled side adjacent tobronchial opening 20 facing a distal direction. Preferably, the shortside is oriented in the direction of the curve of bronchial tube 19, andthe long side terminating in distal tip 25 is oriented in the directionof tracheal opening 18. When inserted into a patient, the short side ofthe trapezoidal profile faces the lateral direction abutting the lateralwall of the mainstem bronchus opposite the tracheal carina (thebifurcation of the trachea into the two mainstem bronchi), while thelong side of the trapezoidal profile faces the medial direction abuttingthe mainstem bronchus just beyond the tracheal carina. The beveled sideof the trapezoidal side profile faces the lobar bronchi openings in alateral direction, away from the midline.” Bronchial balloon cuff 24,while substantially trapezoidal in profile, preferably is cylindricallyshaped to maximize surface contact with an airway, as depicted in FIG.2.

The advantageous aspect of shaping bronchial balloon cuff 24 with asubstantially right trapezoid side profile can be seen in FIG. 6.Anatomically, the RMB is shorter than the LMB. To be a truly universaldesign, the right trapezoid side profile enables bronchial balloon cuff24 to securely fit in both the RMB and the LMB. As shown in FIG. 6, aproperly oriented device 10 places the long side of bronchial ballooncuff 24 against the carina, or the medial side of the trachealbifurcation, for greater surface area grip and traction. The short sideis placed against the right mainstem bronchus lateral wall, facing theright upper lobe (RUL) takeoff. On average, the RMB is only about 15 mmlong, and can be as short as 10 mm or less, and the short side isspecially designed to securely fit against this short distance withoutoccluding airways. The beveled side thereby faces laterally, pointingbronchial opening 20 towards the bronchial airways for unobstructedairflow.

Another advantageous aspect of shaping bronchial balloon cuff 24 with asubstantially right trapezoid side profile can be seen in FIG. 7.Regardless of whether device 10 has been inserted into the LMB or RMB,proper placement will always cause the beveled side to orient bronchialopening 20 toward the bronchial airways. FIG. 7 illustrates a simulatedinsertion of device 10 into a LMB (FIG. 7A) next to a simulatedinsertion of a traditional device into a LMB (FIG. 7B). The curved redline represents the LMB medial wall. It is clear from FIG. 7 that withthe unique right trapezoidal construction of bronchial balloon cuff 24,the beveled side faces laterally and points bronchial opening 20 awayfrom the airway wall and towards the distal airway, while thetraditional device comprises a bevel that is oriented in the opposite,medial direction, and is partially occluded by the airway wall. This isespecially important when considering certain operations orient asubject on his or her left side, such as in right sided lung surgery.The weight of the heart and mediastinal structures pushes on the airway,which in certain subjects leads to the medial wall of the left mainstembronchus pushing against and occluding the bronchial opening of atraditional device.

As will be understood by those having skill in the art, a universalbronchial balloon cuff 24 is not limited to a substantially righttrapezoidal design. Non-limiting universal designs for bronchial ballooncuff 24 include any trapezoidal design, a parallelogram design (FIG.8A), and a curved design (FIG. 8B). The commonly shared feature amongthe different universal designs is a distal tip 25 adjacent to a beveledor angled face.

In various embodiments, the devices of the present invention furthercomprise a lubricant coating. The lubricant coating can be placed on theoutside of the device (e.g., the exterior of shaft 12, bronchial tube19), on the inside of the device (e.g., the inner surface of tracheallumen 28, bronchial lumen 30), or both. The lubricant coating can aid inthe insertion of the devices into the airways of a subject. Thelubricant coating can also aid in the insertion of various instrumentsinto the device tracheal lumen and bronchial lumen. The lubricantcoating, being bonded to the device, avoids the need to continuously addlubricant during use. In certain embodiments, the lubricant coating iswater activated and hydrophilic, wherein the addition of small amountsof water or saline to the lubricant coating creates a very slick surfacewith a low frictional coefficient. The lubricant coating resists quickdrying and is resilient, such that it remains bonded to the deviceduring use. The lubricant coating can be any suitable lubricant coating.In some embodiments, the lubricant coating comprisespolyvinylpyrrolidine (PVP). In some embodiments, the lubricant coatingfurther comprises an antibiofilm or antibacterial material.

In various embodiments, the devices of the present invention furthercomprise one or more sensors for various detection means. For example,in one embodiment, an exemplary device 10 further comprises one or morepressure sensors. The pressure sensors can provide a real-timemeasurement of the tracheal balloon cuff pressure, the bronchial ballooncuff pressure, or both. In some embodiments, the pressure sensorsdisplay whether the pressure is in a safe range or in an unsafe,over-inflated range. The display can be digital (LCD, LED) display or ananalog (gauge) display. Additional non-limiting examples of sensorsinclude flow sensors, temperature sensors, CO₂ sensors, and the like.

Double Clamp

The present invention also provides a double clamp that improves uponthe limitations of traditional devices. The double clamp allows anoperator to switch between clamping the two tubes of a Y-adapter withoutthe risk of accidentally clamping both tubes at the same time.

Referring now to FIG. 9, an exemplary double clamp 40 is depicted.Double clamp 40 comprises frame 42 and a first and a second, oppositelyoriented tube hole, each having an open region 44 and a restrictingregion 46. The opposite orientation of the two tube holes is such thatopen region 44 of the first tube hole is adjacent to restricting region46 of the second tube hole, and the open region 44 of the second tubehole is adjacent to restricting region 46 of the first tube hole. Aportion of the open region 44 of the first and the second tube holeoverlap in the middle of frame 42.

The two tubes of a Y-adapter may be inserted into the first and thesecond tube holes of double clamp 40 such that the tubes rest in themiddle of frame 42, wherein the open region 44 of the first and thesecond tube hole overlap. The tubes may be individually clamped bypushing one of the two tubes into a restricting region 46 of a tubehole. Y-adapters are constructed with the two tubes adjacent to eachother. Therefore, pushing one of the two tubes into a restricting region46 of a tube hole thereby requires that the adjacent tube be pushed intothe open region 44 of the adjacent tube hole. As a result, it isunlikely that both tubes of a Y-adapter are simultaneously pushed into arestricting region 46, which would dangerously cut off all airflow to asubject.

In another embodiment, double clamp 40 can be described as a planarframe having first and second adjacent slots forming first, second andthird tube engagement positions, wherein the first slot is sized torestrict flow through a tube in the first tube engagement position, andthe second slot is sized to permit flow through a tube in the first tubeengagement position; wherein the first slot is sized to permit flowthrough a tube in the second tube engagement position, and the secondslot is sized to permit flow through a tube in the second tubeengagement position; and wherein the first slot is sized to permit flowthrough a tube in the third tube engagement position, and the secondslot is sized to restrict flow through a tube in the third tubeengagement position.

Double clamp 40 can be constructed from any suitable material, such as ametal, a hard plastic, or a rigid but slightly pliant plastic. In someembodiments, double clamp 40 is provided as a standalone clamp to beinstalled onto any suitable Y-adapter tube. In other embodiments, doubleclamp 40 is preassembled around Y-adapter tubes for use with anysuitable ventilation device. In some embodiments double clamp 40 furthercomprises one or more features that enhance ergonomics, such as grips 48(FIG. 10).

The devices of the present invention can be made using any suitablemethod known in the art. The methods may vary depending on the materialsused. For example, devices substantially comprising a plastic or polymermay be milled from a large block or injection molded. Likewise, devicessubstantially comprising a metal may be milled, cast, etched, ordeposited by techniques such as chemical vapor deposition, spraying,sputtering, and ion plating. In some embodiments, the devices may bemade using 3D printing techniques commonly used in the art.

EXPERIMENTAL EXAMPLES

The invention is further described in detail by reference to thefollowing experimental examples. These examples are provided forpurposes of illustration only, and are not intended to be limitingunless otherwise specified. Thus, the invention should in no way beconstrued as being limited to the following examples, but rather, shouldbe construed to encompass any and all variations which become evident asa result of the teaching provided herein.

Without further description, it is believed that one of ordinary skillin the art may, using the preceding description and the followingillustrative examples, utilize the present invention and practice theclaimed methods. The following working examples therefore, specificallypoint out the preferred embodiments of the present invention, and arenot to be construed as limiting in any way the remainder of thedisclosure.

Example 1: Distal Balloon Cuff Development

A double lumen endotracheal tube (DLT) contains a distal component thatsits in the mainstem bronchus. A balloon cuff is inflated to create anair seal necessary for positive pressure ventilation. There are twoconfigurations: a left sided configuration and a right sidedconfiguration. They are named based on the mainstem bronchus that thedistal component resides. Because the anatomy of the left andright-sided mainstem bronchus differs, the design of the distalcomponent, including the balloon cuff, also differs. The right mainstembronchus is short as compared to the left mainstem bronchus, and if theleft DLT distal component design were to be used in the right mainstem,it would likely occlude the opening to the right upper lobe. For thisreason, a different design, encompassing an off center balloon cuff witha side peering orifice, is used for the R sided DLT. See FIG. 11 fordetails about right vs. left bronchus, and FIG. 12 for traditional DLTright and left designs.

The present study investigates the design of a distal component thatwill fit into the right mainstem bronchus without occluding the rightupper lobe (RUL). At the same time, the component must fit in a securefashion, so that it does not easily dislodge out of the bronchus andinto the trachea. Therefore, a balance is needed wherein the tip is nottoo long, but at the same time, has enough length to make proper surfacecontact such that friction holds it in place. The balloon cuff mustocclude the bronchus completely so that there are no air leaks. Finally,the distal component must also fit into the left mainstem bronchus, andalign the device's bronchial opening with the lobar airways.

The present research makes use of collected airway anatomy data fromnearly 200 patients of differing age, weight, height, race, etc., withthe purpose of representing a heterogeneous population. Next, the rightmainstem bronchus (RMB) was identified from CT images, and its relevantdimensions measured (FIG. 13). FIG. 14 is a schematic that illustratesthe airway anatomy, the location of the balloon cuff, and the relevantnomenclature (naming of the dimensions). The data was then analyzedstatistically in order to get a better sense of the variability betweenpatients. This data was then compared to previously published datadescribing human trachea and mainstem bronchi dimensions, and the entirecombined data set utilized in designing the bronchial cuff. Given thatthe design will have to fit in nearly all patients, this data wasexamined to better understand the extreme values that are seen in somepatients. In particular, a short right mainstem bronchus is the mainchallenge, as it does not leave adequate room to position the distalmember appropriately.

In each CT cut, the following lines were drawn and dimensionsmeasured: 1) RMB1, 2) RMB2, 3) RMB3, 4) RMB4 (see FIG. 13). RMB1 is thelength of the RMB on the RUL side. RMB2 is the diameter of the RMB fromthe tip of the carina drawn perpendicularly to the opposing wall of theRMB. RMB3 is the length of the RMB on the carina side. RMB4 is thediagonal line that connects the distal ends of RMB1 and RMB3 together(FIG. 14). All dimensions were measured in millimeters. The dimensionswere drawn as closely as possible to the anatomy, with the limitationthat the anatomy was not always amenable to straight lines givenvariability and other circumstances.

The RMB is shorter than the LMB because of the anatomic takeoff of theRUL. Specifically, the official length of the RMB is RMB1, as measuredin the CT cuts. It is this dimension that limits the length of theballoon cuff, as a balloon that is too long could occlude the opening ofthe RUL when positioned in the RMB. FIG. 15A through FIG. 15C illustratethis point. FIG. 15A demonstrates the ideal dimensions of the ballooncuff; RMB1 reaches up to but does not cross the RUL bronchus takeoff.FIG. 15B illustrates an example where the balloon is too long andcrosses the RUL takeoff, thus occluding the RUL from ventilation. FIG.15C shows a balloon cuff that is too short relative to the RMB. Althoughit does not obstruct ventilation, it is not ideal because its contactsurface at the short (RMB1 dimension) is minimized, as well as itsfriction with the airway. This deficiency could make the cuff morelikely to dislodge. Furthermore, the shorter the cuff, the higher theprobability that small dislodgements will disrupt lung isolation, as itwill temporarily disengage from the RMB inlet and break the bronchialairway seal. Thus, an ideal balloon cuff would have the longest possibledimensions of RMB1 while still fitting into the vast majority ofpatients without obstructing the RUL takeoff.

Given these limitations in RMB anatomy, the CT data was collected in agroup of heterogeneous surgery patients with the goal of betterelucidating the relevant dimensions accurately. Previous attempts to doso relied on bronchoscopy derived or post-mortem measurements, which areinherently subjective and/or inaccurate. Any patients with abnormallydistorted anatomy were excluded, as would occur with a large tumor.Below is Table 1 containing a summary of the findings:

TABLE 1 RMB1 RMB2 RMB3 RMB4 N = 193 (mm) (mm) (mm) (mm) Average 14.013.8 24.1 18.7 Maximum 24.4 21.1 36.1 27.0 Minimum 6.6 6.8 10.4 10.4 STDDEV 3.8 2.3 4.7 3.2 RMB1# < 10 mm 26 RMB1# < 9 mm 13 RMB1# < 8 mm 4RMB1# < 7 mm 1

An exemplary balloon cuff should encompass the following dimensions: 1)a short side of 10 mm in length, 2) a long side of 15 mm in length, 3) abeveled edge that connects the short side and the long side, and 4) aninflation to neutral (non-stretched) diameter of 24 mm.

If this device were to be tested on the patient population (n=193) thatwas studied, this balloon would fit well into nearly all patients' RMB.Specifically, the current balloon cuff dimensions are expected to be agood fit for 188 patients, a marginal fit for 3 patients, and a poor fitfor 2 patients. Even in the marginal and poor fit patients, the deviceis very likely to still function properly in the RMB, as gas flow isstill able to navigate corners and angles, and even partially obstructedairways will still be able to receive gas-flow. These performancestatistics are better than those of the current right-sided DLT designs.

Once a prototype of this balloon shape is developed, in vitro as well asin vivo tests (animal studies first, then human studies) would be neededto determine both its ability to fit in the RMB as well as to seal theRMB and isolate the lung. A preliminary study fitted a prototype of thisballoon shape with a standard ETT shaft into a cadaver airway, and theresults indicated that the prototype balloon shape fit well.

Ideally, the balloon would collapse as flat as possible when deflated,and inflate such that the short side and the long side are flat and makemaximal contact with the bronchial surface (like a tire), rather thanhaving a curvature (radius). Also ideally, the texture of the balloonsurface would be somewhat “roughened”, such that it would not becomeslippery when wet. This would aid in keeping the balloon in place byincreasing the friction at the contact surface between the balloon andthe bronchial wall. Given that static friction between two objects isthe frictional coefficient multiplied by perpendicular force, clinicalpractice has been to maximally inflate balloons to increase theperpendicular force given the very low frictional coefficient. If aballoon has a higher friction coefficient, the cuff could be inflatedless as a bigger force would not be needed, thus potentially reducingairway mucosal ischemia and injury.

Example 2: Membrane Durability Test

The present study examines the durability of a 0.5 mm semilunar membranein response to puncture from endotracheal tube stylets or other sharp,hard objects inserted into the lumen of an endotracheal tube.

The semilunar orifice is tested given that it has the smallest innerdiameter (ID) and needs to deform to accept a stylet, maximizing thefriction and thus the chance that the membrane will perforate. Thefull-length extruded shaft with lubricious coating applied to theinternal diameter of both lumens was tested, although the device was dryto maximize friction and to take the coating out of the equation. A 15mm universal connector was attached to the proximal end of the semilunarlumen, completely obliterating both lumens on that side. On the distalend, a round tube was inserted such that the other lumen (round) isstill patent and in continuity with the atmosphere, and the connectionbetween the tube and semilunar lumen was silicone sealed to prevent leak(FIG. 16). The proximal connector was then connected to an anesthesiamachine. With the thumb sealing the distal end, the pressure was slowlyramped to determine that there is no leak and that the membrane does notperforate or fail at pressure FIG. 17. Once this was completed, thealuminum stylet to be used in the final device was introduced in a roughfashion numerous times. The stylet tips were bent at increasing angles,beyond what would be done in clinical practice, to simulate extremelyrough handling of the endotracheal tube. At the extreme, the stylet tipwas bent at around 35 degrees such that it would just barely traversethe 15 mm connector. As the stylet exited the connector into the shaft,the tip was aimed directly into the semilunar membrane convexity toincrease probability of a “stabbing” penetration into the divider. Nolubrication or hydration was added during these insertions. Afternumerous insertions, the device was pressure tested again. Any smallperforations would cause a leak as the pressurized air would enter theround lumen through the perforation and then exit the atmosphere throughthe distal round lumen aperture (FIG. 18).

Initial pressurization: the device was pressurized on the anesthesiamachine to a pressure of 75 cmH₂O without any evidence of ill effects onthe membrane. This is the maximum achievable pressure on the machine,and would be several times higher than would be clinically safe.

Rough stylet insertion: dozens of intentionally rough insertions wereperformed. After roughly a dozen, the device was pressure tested to 75mmH2O. This was repeated numerous times, with increasing roughness andstylet tip angling, to force the stylet tip to deform and drag againstthe convex side of the membrane. The membrane was observed to stretch atthe initial contact point where the very bent stylet was pushingdirectly into it, before giving way and allowing the stylet to advancefurther into the shaft. Even at this maximal friction and angled roughinsertion, the membrane did not tear. At no point did the membraneintegrity become compromised.

In conclusion, the semilunar membrane is resistant to puncture anddisruption. It easily absorbed punishment beyond what would be expectedin clinical use without failing. Both high pressures from gas and angleduncoated aluminum stylets to be packaged with the product failed todamage its integrity.

Example 3: Testing Bronchoscope Extrusion 80 Durometer and 0.5 mmDividing Membrane

The following study tests 80 D semilunar lubricant-coated extrusionswith co-extruded fill tubes n=16 from the same lot for performance usinga 5 mm and 6 mm bronchoscope. The lot contains 50 units, 30 coated and20 uncoated. 4 samples are tested in each of the 4 lubricatingconditions outlined below, for a total of 16 samples tested.

The extrusions were prepared based on the following lubricatingconditions: 1) extrusions 1-4: water based lubricant jelly on scope only+10 cc saline in extrusion ID (5 cc in each lumen); 2) extrusions 5-8:water based lubricant jelly on scope+extrusion submerged in water for120 s; 3) extrusions 9-12: water based lubricant jelly on scope+10 ccsaline in extrusion+water based lubricant jelly in extrusion ID; 4)extrusions 13-16: water based lubricant jelly on scope+extrusionsubmerged in water+water based lubricant jelly in extrusion ID.

Extrusions were individually inspected by hand, and labeled #1-16, asdescribed above. One extrusion from each group was measured for criticaldimensions as previously described. Extrusions were visually inspectedfor imperfections and then tested as follows: 1) were lubricated intheir respective manner; 2) both a 5 mm and 6 mm bronchoscope wasinserted into both lumens; 3) ease of the insertion and removal testswas scored (5 point scale); 4) samples that were deemed inferior, likelydue to the lubricating protocol, were then “rescued” by redoing the testwith protocol #3 (the previous standard); 5) state of the coating(peeling, flaking) was examined.

The 5-point scale is as follows: 5—scope drops in with no resistance(full length of extrusion); 4—scope slides in with minimal resistance(minimal resistance at the last 10 cm); 3—scope inserts in with someresistance (some resistance at the last 10 cm); 2—scope inserts in withmoderate resistance (resistance throughout insertion); 1—scope insertsin but cannot pass to the other end due to resistance; 0—scope onlyinserts a few cm and then stops due to friction. A sample must pass withall scopes easily passing all lumens to be considered a pass. The actualbronchoscope dimensions for the 5.0 mm was 6.0 mm, and for the 6.0 mmwas 6.7 mm. Initial results are depicted in FIG. 19.

The testing was aborted after clinically testing a few samples as it wasclear that the dimensions were not to specifications and that thisalteration was significantly affecting the results. The results werereproducible among the 4 samples tested, and the measurements alsosuggested that there was little variability among the different samples.Four samples were measured with calipers (#6, 12, 13, 14), and they allhad very similar dimensions. In conclusion, the performance of theextrusions was a failure compared to later prototype successfulextrusions. The cause of the failure was obvious: the extrusiondimensions were not fully to specifications (please see FIG. 20highlighting inaccuracies in the extrusion dimensions): the membrane wastoo thick on one end of the arch; the membrane was too flat, not archedenough; the outer walls were too thick in places; the overall shape wastoo elliptical; the round lumen was too short, and the semilunar lumenwas too tall. The thickening of the inner membrane as well as thealternation of the lumen shapes directly contributed to the failure. Themembrane was too rigid and short in curvature, such that it did notinvert and deflect away from the scope, as it should when the scope wasinserted into the semilunar lumen. The outer walls were too thick andrigid, and the membrane too short/thick such that the round lumen didnot stretch to accommodate the large scope enough. The round lumen wastoo narrow and the semilunar was too wide, but even this increased widthdid not translate to a performance improvement because of the membrane'sreduced compliance.

In addition, the following observations were made: the thickening of themembrane and outer walls was occurring near the area where the filltubes were located;

the elliptical nature of the extrusion was likely secondary to thethickening of the outer walls; the fill tubes appeared to be positionedwell, although their patency was not tested; there was a longitudinal“striping” seen on the membrane along the length of the extrusion.

Example 4: Clinical Testing of Bronchoscope Extrusion with MultipleDurometers and Grooved Internal Diameter

The following study compares three different durometers of extrusions70, 80, and 90. Each sample was internally coated with water-activatedlubricant. Three samples of each durometer were made for quality controltesting. For this study, n=9 samples were tested (three from eachdurometer).

The testing began with lubrication of the 5 mm and 6 mm bronchoscopeshafts with water based lubricant jelly. The actual measured diametersof the bronchoscope distal tips were 5.2 mm and 6.5 mm, respectively. 5cc of saline was then flushed through each of the extrusion's lumens,and then water based lubricant jelly was squirted into the first 2 cm orso of the extrusion tube. The bronchoscopes were then inserted into thelumens and ease of passage was tested (see outline of steps below).Finally, one extrusion representing each durometer was then placed in a1500 cc bottle of warm water such that the bottom ⅔ of the extrusion wassubmerged in water for a few minutes. The scopes were then inserted inboth lumens again.

Extrusions were visually inspected for imperfections and then tested asfollows: 1) wet with saline flush syringes (5 cc at a time) only; 2)water-based lubricant jelly was then added; 3) both a 5 mm and 6 mmbronchoscope was inserted into both lumens; 4) ease of insertion andremoval were compared (5 point scale); 5) state of the coating (peeling,flaking) was examined.

The 5-point scale is as follows: 5—scope drops in with no resistance(full length of extrusion); 4—scope slides in with minimal resistance(minimal resistance at the last 10 cm); 3—scope inserts in with someresistance (some resistance at the last 10 cm); 2—scope inserts in withmoderate resistance (resistance throughout insertion); 1—scope insertsin but cannot pass to the other end due to resistance; 0—scope onlyinserts a few cm and then stops due to friction. The results aredepicted in FIG. 23.

The following observations were made: the dimensions of the extrusionwere different from previous runs. Although the extrusion was neverround in cross section (the design states 13 mm radius), three randomlyselected samples from previous runs had the following ellipticaldiameters (mm): 1) 13.5×12; 2) 13.3×12; 3) 13.2×12.2. The first valuerepresents the long diameter and the second represents the shortdiameter. The current extrusions were more elliptical than the previousones, and also varied by durometer. The 70 D diameters for the threesamples were as follows (mm): 1) 14.0×11.8; 2) 14.3×11.9; 3) 14.2×12.0.The 80 D diameters for the three samples were as follows (mm): 1)14.5×12.2; 2) 14.7×12.4; 3) 14.6×12.3. The 90 D diameters for the threesamples were as follows (mm): 1) 13.9×11.9; 2) 13.9×11.9; 3) 13.6×11.9.The 90 D samples were the least elliptical and most closely resembledthe previous extrusions.

The wall thickness of the extrusion was supposed to be 1.5 mm, but inthe present batch, the wall thickness varied. The 70 D wall thicknesseswere not measured. The 80 D walls were thicker than they were supposedto be (see below). The 90 D walls were the correct thickness.

The 80 D wall thicknesses measured at each lateral free walls (value 1and 2) and near the membrane junction (value 3) were as follows (mm):sample 1: 1) 1.67, 2) 1.86, 3) 2.00; sample 2: 1) 1.70, 2) 1.80, 3)1.90; sample 3: 1) 1.60, 2) 1.70, 3) 1.90. The 90 D wall thicknessesmeasured at each lateral free walls (value 1 and 2) and near themembrane junction (value 3) were as follows (mm): sample 1: 1) 1.40, 2)1.50, 3) 1.50; sample 2: 1) 1.50, 2) 1.50, 3) 1.50; sample 3: 1) 1.50,2) 1.50, 3) 1.60.

The grooves reduce the friction when the silicone is dry, but actuallyincrease the friction when the silicone is lubricated, when compared toa control sample that has no grooves. This result was reproduced on theprevious sample from which the grooves were modeled.

The results indicate: the extrusion should be round and have an OD of 13mm; the extrusion ID should have a water-based lubricant coating; theextrusion ID should be completely smooth, without any grooves; the innermembrane works best when it is slick and flexible; the inner membranemust be able to deflect, but also resist kinking; the durometer needs tobe at least 70 D to resist shaft kinking; higher durometers improve kinkresistance but limit membrane flexibility.

The disclosures of each and every patent, patent application, andpublication cited herein are hereby incorporated herein by reference intheir entirety. While this invention has been disclosed with referenceto specific embodiments, it is apparent that other embodiments andvariations of this invention may be devised by others skilled in the artwithout departing from the true spirit and scope of the invention. Theappended claims are intended to be construed to include all suchembodiments and equivalent variations.

1-19. (canceled)
 20. A double clamp device, comprising: a planar framehaving first and second adjacent slots forming first, second and thirdtube engagement positions; wherein the first slot is sized to restrictflow through a tube in the first tube engagement position, and thesecond slot is sized to permit flow through a tube in the first tubeengagement position; wherein the first slot is sized to permit flowthrough a tube in the second tube engagement position, and the secondslot is sized to permit flow through a tube in the second tubeengagement position; and wherein the first slot is sized to permit flowthrough a tube in the third tube engagement position, and the secondslot is sized to restrict flow through a tube in the third tubeengagement position.
 21. The device of claim 20, further comprising oneor more grips.
 22. The device of claim 20, wherein the second slot has ashape that is substantial equal to a shape of the first slot that isrotated by 180° within the planar frame.
 23. The device of claim 20,further comprising a Y-adapter tube, wherein the Y-adapter tubecomprises a primary tube section split at a Y-end into a first tubebranch and a second tube branch, such that the first tube branch ispositioned within the first slot and the second tube branch ispositioned within the second slot.